Overview:
The Life Sciences industry is one of the most highly regulated markets in the world, and with good reason. For the people responsible for getting pharmaceuticals and medical devices on the shelves and in hospitals, it means ensuring that all information produced in the packaging process – inserts, labels, cartons, etc. to be 100% error free.
This responsibility – to get everything right – often falls on Regulatory Affairs where the workload is high, and deadlines are short.
Watch the webinar, with special guest Collette Rohan, Director of Regulatory from NorthStar Health, as we take you through the challenges faced by Regulatory Affairs in the UK when it comes to ensuring the accuracy of all digital and printed material as well as strategies to increase output by reducing your proofreading workload.
Length: 54 minutes
Learning Objectives:
Experience a live case study from NorthStar Health: How they transformed their document review process using software
How to choose the best software for your team
Tips to successfully overcome challenges that slow down time to market and increase the chances of errors
Effective best practices to avoid mistakes in the proofreading process
Actionable strategies for an effective process that leads to content accuracy, data integrity and reduced workloads
Who Should Watch:
Supply Chain & Regulatory Affairs Professionals
Service Providers for Life Sciences
Presenters:
Dean Halliday
Regional Sales Director, Schlafender Hase
Dean Halliday has been working with customers in highly regulated markets for over a decade and specialises in working with the Life Science Industry.
Ensuring that the related risks of manual proofreading and approval processes are identified and solved quickly and easily, allowing only approved content to be printed or published.
Dr. Jutta Hohenhoerst
Regional Sales Director, Schlafender Hase
Dr. Jutta Hohenhoerst has more than 22 years experience in the pharmaceutical business. She has practiced in different departments from Supply Chain Management to Strategic Marketing at F. Hoffmann-La Roche HQ, AstraZeneca and Fresenius HQ.
While working for IQVIA during 2005 and 2012, she broadened her knowledge through strategic consulting projects in the pharma, medical device and hospital sector.
Collette Rohan
Director of Regulatory Affairs, NorthStar Healthcare
Collette has over 25 years of experience in FDA-regulated manufacturing. Before joining NorthStar in 2010, Collette was Head of Regulatory Affairs for Corden Pharma, an Active Pharmaceutical Ingredient manufacturer based in Little Island, Cork.
Since joining NorthStar, Collette has focused on the contract manufacturing and sourcing of private label generic drugs with an emphasis on regulatory compliance, product labelling and post marketing surveillance. Collette’s team has broadened the scope of their activities from FDA ANDA submissions to adverse drug event and field alert reporting, as well as adherence to other regulatory body requirements including Custom and Border Protection, Drug Enforcement Agency and McKesson Trade Agreement Act compliance.
